# FDA recall D-1464-2016

> **Stratus Pharmaceuticals Inc** · Class III · drug recall initiated 2016-05-26.

## Product

Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz  (142 g) and b) 9.0 oz  (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ.  Distributed by Stratus Pharmaceuticals Inc., Miami, FL.

## Reason for recall

Crystallization; Complaints that cream appears to have crystallized

## Distribution

Nationwide and PR

## Key facts

- **Recall number:** D-1464-2016
- **Recalling firm:** Stratus Pharmaceuticals Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2016-05-26
- **Report date:** 2016-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1464-2016

## Citation

> AI Analytics. FDA recall D-1464-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1464-2016. Source: US FDA. Licensed CC0.

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